FDA reviewed additional information to ensure generic is as safe and effective as brand-name drug
THURSDAY, April 16, 2015 (HealthDay News) — The first U.S. generic version of Copaxone (glatiramer acetate injection) has been approved by the Food and Drug Administration to treat multiple sclerosis.
The brand-name drug is produced by Israel-based Teva Pharmaceuticals. License to produce the generic equivalent of Copaxone was issued to the Swiss-based drug maker Sandoz, the FDA said Thursday in a news release.
The most common side effects of Copaxone include injection-site redness and pain, vasodilation, rash, shortness of breath, and chest pain.
“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand-name product.”